I spoke to “the Mrs” just before the announcement of these results. I said, “I am sure it would be more of the same, with the only decent bit being the closing remarks”. Sure enough, Silviu did not let us down. Just when i was screaming at my screen for one analyst, JUST ONE ANALYST, to ask the elephant in the room question...to put Silviu’s feet to the fire, about when will (or has),the last patient be interviewed for the Revascor trial ? How long should we expect data cleaning of the database to take ? When will the database be locked ? How long from database lock to potential headline read outs ? Will management be unblinded before or after independent statistical review ? Just so we can have some informed opinion about timings. We all know data read outs will be mid year....but even a dodo knows that headline numbers are announced well before that !!! ... come on Silviu, your shareholders deserve a better steer....but Silviu was having none of it.....but at least he purred a few words, which were gently uttered in his last velvety smooth breaths of the conference call. It was a though he was taunting all those analysts for not asking the obvious questions.....these are very exciting times and we will shortly “update the market in due course on some key milestones”....or words to that effect..a sort of “watch this space comment” which i have grown to like but at the same time, hate,because no one can ask a supplementary question afterwards. Is he is referring to the “priority review’ for the BLA? , or another subject already covered in the conference call ? ...or was he hinting at something else for us to salivate over. Judging by past form, i suspect it is something new and exciting....but I am sure i will be derided as a fantasist by our resident naysayers ! As to the last patient visit, we all know the interview was supposed to take place at the end of January at the latest....so why the slide which says “final study visits have been initiated”. Come on Mesoblast ...why the obfuscation ? Your killing us ! Did anyone explain the financial markets are in turmoil and we are supposedly in a “risk off environment” ! Why do i have to feel like some slave to the cause being manically taunted by every presentation slide.....worse than a Puritanical priest twisting his cilice, as he chants obeyance to the faith !
At least be consistent. Mesoblast guided that the last patient to be interviewed on the CLBP trial would be towards the end of the current quarter at the JP MORGAN Conference....so why not tell us the same information for a heart trail where we know the last patient was supposed to be interviewed by the end of January ? I suggest that everyone listen again to that JP MORGAN webcast because it supplies you with considerably more substance than anything we heard today...with a few notable exceptions. Just as we were feeling satiated by the ever expanding label extension opportunities, Silviu casually mentions in a reply to analyst Jason Kolbert about end stage heart failure that our therapy looks to have potential in Coronary By Pass Surgery....Come on Professor, you might wish to remind everyone that with 500,000 operations a year, Coronary By Pass Surgery is one of the most common major operations performed in US hospitals every year !
Let us not forget that post a successful BLA application for Ryoncil we are about to cross over to the TWILIGHT ZONE. This is where companies have FDA approved therapies and ever expanding share prices as all those label extensions get fast tracked through the regulatory mire.
Oh those beautiful label extensions !!! HIE, EB, Adult and Chronic SR GVHD . Each one represents significant revenue streams in their own right. Let’s not forget chronic GVHD is a much bigger market than paediatric sr GVHD. In our first three patients receiving two doses of Remestemcel under early look trials with Prof Kurtzberg we achieved a “substantial responses” in under 28 days ....when “gold standard” therapy Imbruvica was quoted as needing 6-9 months... for those patients which do respond ! Did any of the analysts ask about the Crohns phase 3 trial which is now prominently referred to in one slide ? If the company wants to extend the label for Remestemcel-L to a potential market for 80,000 refractory Crohns patients ....is that not important ? If Alofisel has already been approved for perinatal fistula using a similar method of action, have we any real reason to doubt its clinical success in our trials...other than the degree of efficacy ? I mean this Crohn's trial has been going on for 10 years are we just gluttons for punishment ? Who else noted the added emphasis on the LVAD, end stage therapy opportunity.... which had previously “disappointed” because the sponsor cocked up in using thrombotic LVAD devices for a significant element of the patient group. People often forget the amazing results achieved in the phase 2 clinical trial which preceded the clotty 159 patient one, which was a 2 for 1 randomised placebo controlled trial with 30 patients, where our therapy trounced the control and successfully improved and in many cases weaned up to 70% of patients from their LVAD devices while the control managed just 2 out of 10.
I must admit, I find these analysts calls very light on information. When one analyst asked a pretty basic question about modelling expenses for the next 12-24 month, the CFO could not supply a range, even though the next quarters costs are always shown in statutory documents filled for the NASDAQ listing. I appreciate some numbers may change, but it is hardly satisfactory to be left unable to calculate cash burn... Even more frustrating is that the answer is probably one which is very positive, as he disclosed lower clinical trial expenses in the near future as most of the major clinical trials were drawing to a close. It is also bizarre that $2.5m of income can be paid by Grunenthal for a milestone achieved and then the auditors do not allow its inclusion in the reporting period. Obviously Grunenthal thought the milestone had been achieved because that is what a “milestone” represents ! These are not important matters. I totally trust the management team, but as shareholders are the owners of the business it is appropriate to answer questions at these forums. Oh well, not to worry, i am sure Bell Potter will miraculously produce detailed guidance in the next 24 hours...all complete guesses of course ! I suspect the real problem is that every one is tip toeing over the daisies so as not to upset the FDA. After all it is in their hands to demand confirmatory trials or impose some other restrictions which will leave more sick children bereft of a therapy which has not only outstanding results but virtually no side effects...in marked contrast to our competitors products !!!
These interim results were announced at a particularly sensitive time in relation to discussions with the FDA. I know the Company is acting in all our interests in wanting to show complete discretion in proceedings ...so the majority of my above comments are made in either jest or frustration....but be in no doubt....I bought more shares in the market today before i pushed the send button for this post. I do not have the foggiest idea what the Revascor trial will reveal but i will make an educated guess that It is likely to be very successful... my guess is backed up by 1) an interim futility test which tested safety and efficacy of primary endpoints which was successfully passed 2) the recent comments of the Data Monitoring Controller at the end of the trial, who is the only person who is unblinded throughout. 3) Mesoblast having already achieved a major reduction in ischemic cardiac bleeding events in the independently sponsored LVAD trials 4) the amazing placebo adjusted Results of the phase 2 MPC150m dosage in showing significant improvement in systolic performance of the left ventricle. 5) etc.etc.,
Not long to wait ! I think Silviu likes to give surprises....he will soon be freed from his red tape and can sing like a canary. Come on Mesoblast !
Now. Keep Calm and carry on !
Please do not rely on the opinions expressed or information provided in the above post, when making an investment decision . Black swan events like the Coronavirus should serve as a timely reminder that using leverage in share investing can be particularly dangerous at times of high market volatility . OP
(20min delay)